[Translation] A prospective, randomized, double-blind, parallel controlled clinical study on the immunogenicity and safety of recombinant hepatitis B vaccine and monovalent hepatitis B vaccine in neonates
本研究的主要目的是论证重组乙型肝炎疫苗Hepavax-Gene TF与对照疫苗相比在阻断乙型肝炎从乙肝阳性的母亲传播至其子女的非劣效性以及母亲乙型肝炎阴性的新生儿完成免疫接种计划后一个月血清保护率的非劣效性
[Translation] The primary objectives of this study were to demonstrate the non-inferiority of the recombinant hepatitis B vaccine Hepavax-Gene TF to the control vaccine in blocking the transmission of hepatitis B from hepatitis B-positive mothers to their children and in the seroprotection rate of newborns of hepatitis B-negative mothers one month after the completion of the vaccination schedule.